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Conduct in Chinese healthy adult subjects:1.To observe the safety and tolerability of multiple-dose oral administration of different doses of PNA;2.By measuring the changing drug concentration in the plasma and urine after a single oral administration of different doses of PNA on the condition of fasting, the pharmacokinetic parameters of the single dose are estimated;3.By measuring the changing drug concentration in the plasma of PNA after a multiple-dose oral administration on the condition of fasting, the pharmacokinetic parameters of multiple-dose are estimated, and a basis for dosage regimens of the clinical research phase Ⅱ is provided;4.To study the effects of diet on the pharmacokinetic parameters via the changes of concentration of PNA in plasma after high-fat and high-calorie food.
The study is divided into three parts:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PNA 1 | Experimental | Multiple dosing tolerance test:Metacavir Enteric-coated Capsules 160mg/320mg,once a day,continuous administration for 7 days; |
|
| PNA placebo | Placebo Comparator | Multiple dosing tolerance test:Metacavir Enteric-coated Capsules placebo 160mg/320mg,once a day,continuous administration for 7 days |
|
| PNA 2 | Experimental | Single dosing pharmacokinetic test:Metacavir Enteric-coated Capsules 80mg/160mg/320mg,single-dose; |
|
| PNA 3 | Experimental | Multiple dosing pharmacokinetic test:Metacavir Enteric-coated Capsules 160mg/320mg,once a day,continuous administration for 6 days; |
|
| PNA 4 | Experimental | The effect of diet:Metacavir Enteric-coated Capsules 160mg,before and after meal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PNA | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| TEAEs | Frequency of treatment-emergent adverse events | day 1 to day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC | Area under the plasma concentration versus time curve of PNA | day 1 to day 7 |
| Cmax | Maximum Plasma Concentration of PNA | day 1 to day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hongwei Fan | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
| Ruifang Wang | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing First Hospital | Nanjing | Jiangsu | China |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| PNA placebo | Drug |
|
|
| T1/2 | The time required while plasma concentration is reduced by half of PNA | day 1 to day 7 |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |